Scancell Holdings (SCLP) Status update summary

Clinical program updates

• SCOPE study is progressing well, with data from Cohorts 1-3 to be shared in July 2025 and interim Cohort 4 data expected by year-end.

• SCOPE is a phase II open-label study in advanced unresectable melanoma, evaluating SCIB1 and iSCIB1+ vaccines in combination with checkpoint inhibitors across 16 UK sites and over 140 patients.

• Early Cohort 1 data show a 72% overall response rate, 84% disease control rate, 80% progression-free survival, 20% complete response, and strong T cell responses, with an excellent safety profile and no significant adverse events in the first 8 patients dosed intradermally.

• Cohort 4 is enrolling rapidly, testing intradermal administration and accelerated dosing, with support from the NHS Cancer Vaccine Launch Pad partnership.

• Plans are underway for a phase IIb/III registration trial in both the US and Europe, with regulatory strategies to mitigate evolving FDA requirements.

Corporate and strategic developments

• Announced the formation of GlyMab Therapeutics, a wholly owned subsidiary to house the antibody portfolio and unlock greater value.

• GlyMab will focus on high-affinity, high-specificity IgG1 antibodies targeting tumor glycans, leveraging a proprietary platform.

• Lead asset SC134 is advancing toward IND as a T-cell engager for small cell lung cancer, with plans to generate clinical data in 24–36 months.

• GlyMab will transfer relevant patents, platforms, and teams, and seek both pharma partnerships and institutional investment.

• Structure allows for specialized focus, operational clarity, and two independent value creation paths for investors.

Financial and shareholder matters

• Company maintains a strong cash runway into the second half of 2026, covering key milestones for SCOPE, ModiFY, and GlyMab.

• Ongoing discussions with Genmab regarding partnered antibody assets, with anticipated future milestone payments.

• Shareholders will benefit from the value created by GlyMab, with future options for direct investment and strategic financing under consideration.

• No specific valuation disclosed for GlyMab, but clinical-stage data is expected to significantly enhance asset value.

• Company is actively engaging with investors and monitoring market conditions to ensure fair valuation and maximize shareholder value.